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Qiagen, Pfizer Collaborate on Companion Dx for NSCLC

NEW YORK (GenomeWeb News) – Qiagen today announced a deal with Pfizer to develop a companion diagnostic for Pfizer's investigational anticancer compound for non-small cell lung cancer.

The test will be based on Qiagen's proprietary KRAS assay technology which detects mutations of the KRAS gene frequently found in human cancers. Qiagen recently submitted applications with the US Food and Drug Administration for pre-market approval for KRAS companion diagnostics for use with two drugs targeting metastatic colorectal cancers.

The test being co-developed by Qiagen and Pfizer is for Pfizer's dacomitinib, an oral inhibitor of HER-1 (EGFR), HER-2, and HER-4 tyrosine kinases. The HER signaling pathway is involved in the complex process of cell growth and metastasis, making it a target for oncology therapies, Qiagen said.

Because EGFR inhibitors are generally effective in patients without KRAS mutations, Qiagen's assay may be useful for the identification of the most appropriate patients for EGFR inhibitors.

The test to be developed uses the same core assay component as the Qiagen's therascreen KRAS RGQ kit for colorectal cancers "but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow," Qiagen said in a statement.

Its partnership with Pfizer includes clinical trails and submission for PMA in the US and CE marking in Europe, as well as regulatory approval in other regions.

Financial terms were not disclosed.

In February 2010 Qiagen's DxS unit and Pfizer announced a companion diagnostic development deal covering a brain cancer treatment.

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